MindChild receives FDA pre-market clearance for MERIDIAN non-invasive fetal heart monitor

MindChild Medical, Inc. today announced that it has received clearance for its Pre-Marketing Notification (510(k)) from the US Food and Drug Administration (FDA) for its MERIDIAN™ non-invasive fetal heart monitor. MindChild anticipates entering the US market with MERIDIAN now that it has received the FDA clearance. Additional pre-market regulatory filings are anticipated during 2012 and 2013.

"We are thrilled to have reached this milestone", stated Bill Edelman, CEO. He continued, "MERIDIAN is the first in a series of non-invasive fetal monitor technologies developed by MindChild that are intended to provide the healthcare community enhanced monitoring capabilities for both fetal heart rate and fetal ECG. We anticipate significant clinical interest for this innovative technology in the markets where MERIDIAN will be cleared for commercial distribution."

Adam Wolfberg, M.D., Chief Medical Officer for MindChild stated, "This FDA pre-market clearance delivers a highly-reliable fetal monitor to the obstetric community. In the coming months and years, MindChild will exploit this technology to improve the safety of obstetrics, and hand a new diagnostic device to obstetricians and pediatric cardiologists."

Thomas Garite, M.D., Director of Research and Education for the Obstetrix Medical Group, and Editor-In-Chief of the American Journal of Obstetricians and Gynecology, commented, "I am excited to note the FDA pre-market clearance of MERIDIAN. Accurate acquisition of the fetal heart rate signal is critical to the safe practice of obstetrics. Chronic increases in maternal obesity/Body-Mass-Index have created new challenges for existing non-invasive fetal heart rate monitoring technologies. This technology cannot help but to improve our ability to make patient decisions. MindChild's Meridian non-invasive fetal monitoring technology may hold the promise of such an advance."